The Treatment of Periappendicular Abscess After the Acute Phase
NCT ID: NCT03013686
Last Updated: 2020-11-12
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
110 participants
INTERVENTIONAL
2013-01-15
2030-12-31
Brief Summary
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Periappendicular abscess is generally initially treated conservatively with antibiotic therapy and if necessary, drainage. Operative treatment in the acute abscess phase is associated with increased morbidity and thus complicated appendicitis with a periappendicular abscess is initially treated conservatively. However, there is debate on whether interval appendectomy is required.
After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular abscess, patients enrolled in the PeriAPPAC study are randomised either to interval appendectomy or to follow-up with MRI at two months after the initial treatment. All patients also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the MRI (outpatient visit at endoscopy unit with information on the MRI).
The primary endpoint is the treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up.
The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital and Seinäjoki Central Hospital.
Detailed Description
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Periappendicular abscess is generally initially treated conservatively with antibiotic therapy and if necessary, drainage. Operative treatment in the acute abscess phase is associated with increased morbidity and thus complicated appendicitis with a periappendicular abscess is initially treated conservatively. However, there is debate on whether interval appendectomy is required.
After initial successful conservative treatment of a CT- or MRI-diagnosed periappendicular abscess, patients enrolled in the PeriAPPAC study are randomised either to interval appendectomy or to follow-up with MRI at two months after the initial treatment. All patients also undergo a colonoscopy, appendectomy patients prior to surgery and MRI patients after the MRI (outpatient visit at endoscopy unit with information on the MRI).
The primary endpoint is the treatment success in both treatment arms. In the interval appendectomy evaluated as possible morbidity related to appendectomy and in the follow-up treatment arm as possible recurrence of the appendicitis and/or abscess during a one-year follow-up.
The PeriAPPAC study is a multi centre trial and the participating hospitals are Turku University Hospital, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital and Seinäjoki Central Hospital.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interval Appendectomy
The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary.
Interval appendectomy is performed at two months after the primary treatment, all patients also undergo colonoscopy prior to appendectomy.
Interval appendectomy
Laparoscopic appendectomy
Follow-up with MRI
The periappendicular abscess, diagnosed by a CT-scan or MRI, is initially treated conservatively with antibiotic therapy and with drainage, if necessary.
The patients undergo abdominal magnetic resonance imaging at two months after the primary treatment, all patients also undergo colonoscopy right after the MRI.
Follow-up with MRI
Abdominal MRI
Interventions
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Interval appendectomy
Laparoscopic appendectomy
Follow-up with MRI
Abdominal MRI
Eligibility Criteria
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Inclusion Criteria
* CT- or MRI-diagnosed periappendicular abscess, that has initially undergone successful conservative treatment with antibiotic therapy and drainage, if necessary
Exclusion Criteria
* Age under 18 years or over 60 years
* Pregnancy or lactating
* Allergy to contrast media or iodine
* Renal insufficiency
* Metformin medication (DM)
* Unsuccessful initial conservative treatment of periappendicular abscess
* Lack of co-operation (unable to give consent)
* A severe medical condition
* Previous acute appendicitis treated conservatively with antibiotics
18 Years
60 Years
ALL
Yes
Sponsors
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Oulu University Hospital
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Paulina Salminen
Principal investigator
Principal Investigators
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Paulina Salminen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
References
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Mallinen J, Rautio T, Gronroos J, Rantanen T, Nordstrom P, Savolainen H, Ohtonen P, Hurme S, Salminen P. Risk of Appendiceal Neoplasm in Periappendicular Abscess in Patients Treated With Interval Appendectomy vs Follow-up With Magnetic Resonance Imaging: 1-Year Outcomes of the Peri-Appendicitis Acuta Randomized Clinical Trial. JAMA Surg. 2019 Mar 1;154(3):200-207. doi: 10.1001/jamasurg.2018.4373.
Other Identifiers
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PeriAPPAC
Identifier Type: -
Identifier Source: org_study_id